BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2802879 · Received October 24, 2012

    Report

    Report Number
    9616099-2012-00608
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    August 19, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW, THE DATE OF THE ADVERSE EVENT WAS CORRECTED TO (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE CC HAS BEEN UPDATED TO INCLUDE THE ENTIRE CONCLUSION A PORTION OF WHICH WAS ACCIDENTALLY OMITTED. THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT HAD A PRECISE 8 X 30 STENT SUCCESSFULLY IMPLANTED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (RICA). THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DEPLOYMENT DIFFICULTY WITH THE 7 MM. ANGIOGUARD DEVICE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. SIX DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE CHARACTERIZED BY DYSARTHRIA. THE ONSET WAS SUDDEN AND THE PATIENT RECOVERED WITH NO RESIDUAL EFFECTS IN LESS THAN TWENTY-FOUR HOURS (<24 HOURS). THE EVENT WAS NOTED AS NOT RELATED TO A CORDIS DEVICE/THE INDEX PROCEDURE OR ANTICOAGULATION. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE INDEX PROCEDURE. THE PROXIMAL RICA TARGET LESION WAS REPORTED TO BE: A 95% STENOSIS, 10 MM. IN LENGTH, TARGET LESION THROMBUS NOTED, 5 MM. REFERENCE DIAMETER, AND SEVERELY TORTUOUS/CALCIFIED. THE LESION WAS PRE-DILATED AND THE RESIDUAL STENOSIS WAS 0%. THE PATIENT'S MEDICAL HISTORY INCLUDES RENAL INSUFFICIENCY, SMOKING, DIABETES MELLITUS AND HYPERTENSION. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15619025 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH; 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 STENT SUCCESSFULLY IMPLANTED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (RICA) DURING THE STUDY INDEX PROCEDURE. THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DEPLOYMENT DIFFICULTY WITH THE 7 MM. ANGIOGUARD DEVICE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE RESIDUAL STENOSIS WAS 0%. SIX DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT/AE OF ISCHEMIC STROKE CHARACTERIZED BY DYSARTHRIA. THE EVENT WAS NOT RELATED TO A CORDIS DEVICE/THE INDEX PROCEDURE OR ANTICOAGULATION. THE ONSET WAS SUDDEN AND THE PATIENT RECOVERED WITH NO RESIDUAL EFFECTS IN LESS THAN TWENTY-FOUR HOURS (<24 HOURS). THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE INDEX PROCEDURE. THE PROXIMAL RICA TARGET LESION WAS REPORTED TO BE: A 95% STENOSIS, 10 MM. IN LENGTH, TARGET LESION THROMBUS NOTED, 5 MM. REFERENCE DIAMETER, AND SEVERELY TORTUOUS/CALCIFIED. THE LESION WAS PRE-DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15619025

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L 7 MM ANGIOGUARD